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News about "National Medical Products Administration (NMPA)"
Innovent's PECONDLE Becomes China's First Approved IL-23p19 Antibody
Innovent has received NMPA approval for PECONDLE (picankibart injection), marking China’s first IL-23p19 monoclonal antibody to be cleared for treating moderate-to-severe plaque psoriasis in adults eligible for systemic therapy.
National Medical Products Administration (NMPA) | 02/12/2025 | By Dineshwori
Zydus Lifesciences Receives USFDA Tentative Nod for Generic Multiple Sclerosis Drug
Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Diroximel Fumarate delayed-release capsules, 231 mg, a generic version of Vumerity delayed-release capsules of the same strength.
National Medical Products Administration (NMPA) | 13/11/2025 | By Dineshwori | 243
Glenmark Secures China's Approval For RYALTRIS
Glenmark Pharmaceuticals has received regulatory approval in China for RYALTRIS. Combining olopatadine hydrochloride and mometasone furoate, it offers dual-action relief from nasal symptoms, further strengthening Glenmark’s position as a global leader in respiratory innovation.
National Medical Products Administration (NMPA) | 11/11/2025 | By Dineshwori | 150
Akeso's Ivonescimab Wins 4th Breakthrough Therapy Nod in China for TNBC
Akeso has secured its fourth Breakthrough Therapy Designation (BTD) in China for Ivonescimab, targeting first-line treatment of triple-negative breast cancer (TNBC). The ongoing Phase III HARMONi-BC1 trial is assessing its safety and efficacy in this hard-to-treat cancer type.
National Medical Products Administration (NMPA) | 03/11/2025 | By Dineshwori | 101
Anbenitamab Set to Lead as First Bispecific mAb in China's HER2+ Gastric Cancer Market: GlobalData
China’s NMPA has accepted Alphamab Oncology’s NDA for KN026 (Anbenitamab), which could become the first bispecific mAb for HER2-positive gastric and GEJ cancer, according to GlobalData.
National Medical Products Administration (NMPA) | 25/09/2025 | By Dineshwori | 161
NMPA Clears Zhimeng Biopharma's Drug for Phase-II Epilepsy Trial
Zhimeng Biopharma’s drug for Phase II epilepsy trial will be evaluated in a randomized, double-blind, placebo-controlled multinational study to test its efficacy, safety, and tolerability as an adjunct therapy in adults with focal epilepsy.
National Medical Products Administration (NMPA) | 13/09/2025 | By Dineshwori | 101
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